Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis

Chinese SLE Treatment And Research Group

Status: Enrolling

Conditions: Lupus Nephritis

Study type: Observational

Funder types: Other

Identifiers

NCT06167174

CSTAR-K2939

Details and patient eligibility

About

This is an observational study of patients with lupus nephritis aiming to find biomarkers that can predict patients' response to immunosuppressants. We planed to collect 100 lupus nephritis patients' peripheral blood,kidney tissues and urine before and after treatment (mycophenolate mofetil or cyclophosphamide, in combination with glucocorticoids). Then multi omics analysis, including single cell RNA-seq, ATAC-seq and CITE-seq, will be performed to find new biomarkers for patients' response and prognosis.

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age between 16-60 years.
2. Fulfilling the 2012 SLICC classification for SLE.
3. Renal biopsy pathology was clearly classified as III \ IV \ V+III \ V+IV within 6 months.
4. Renal biopsy reveals active disease.
5. 24-hour urinary protein was tested twice within two weeks, both of which were greater than 1g.
6. The patients have never received glucocorticoid/immunosuppressants or received standard treatment for more than 1 month without change. The standard treatment should fulfill: a. prednisone 0-20mg/day, or equivalent other glucocorticoids; b. acceptable immunosuppressants, including Tacrolimus ≤ 4mg/d, methotrexate ≤ 15mg/week, azathioprine ≤ 100mg/d and MMF ≤ 1g/d.
7. Informed consent obtained.

Exclusion criteria

1. Other concomitant connective tissue diseases or autoimmune diseases.
2. Neuropsychiatric lupus, alveolar hemorrhage, retinal lesions, pulmonary arterial hypertension, or other severe organ involvement.
3. Pregnant or lactating women.
4. Current infections that require antibiotic or antiviral treatment.
5. Other kidney diseases.
6. Platelet < 50×10^9/L.
7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is greater than 1.5 times the upper limit of the normal value.
8. Total bilirubin or blood lipid that is greater than 2 times the upper limit of the normal value.
9. Other conditions that not suitable for inclusion in the study, assessed by the investigators.

Trial design

100 participants in 2 patient groups

MMF treatment

Description:

Patients that have been diagnosed as III/IV ± V LN and treated with MMF 2g/d in combination with glucocorticoid.

CYC treatment

Description:

Patients that have been diagnosed as III/IV ± V LN and treated with CYC 0.5g IV per two weeks in combination with glucocorticoid.